As a Senior Quality Engineer, you safeguard the systems that let clinicians and patients rely on every Mynarix batch. You lead investigations, drive continuous improvement, and ensure our manufacturing meets current good manufacturing practice at every step.
What you'll do
- Lead deviation, CAPA, and root-cause investigations across manufacturing lines.
- Review and approve batch records, validation protocols, and change controls.
- Partner with production to embed quality-by-design into daily operations.
- Support internal and regulatory audits, including FDA and WHO-GMP inspections.
What you'll bring
- ✓Bachelor's in engineering, pharmacy, or life sciences; 5+ years in pharma quality.
- ✓Deep working knowledge of cGMP, ICH, and FDA 21 CFR Parts 210/211.
- ✓Experience leading investigations and authoring CAPAs in a regulated environment.
- ✓Strong data analysis and cross-functional communication skills.
1 About you
2 Experience
3 Questions